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Disclaimer

These guidelines exist as an aid to organisations in assessing the medical suitability of their potential donors. Please be reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.

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About the WMDA donor medical suitability guidelines

Guidance provided by the World Marrow Donor Association (WMDA) aims to provide minimum standards by which potential donors should be assessed. The WMDA guidance reflects the consensus opinion of the WMDA donor medical suitability committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.

Whilst this WMDA guidance is not specifically intended for related donors, those involved with the medical assessment of related donors should consider these recommendations.

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How donor medical suitability is assessed

Two key concepts govern the assessment of donor health, namely restrictive criteria for donor risk and more permissive criteria for recipient risk

Donor risk

Donation of hematopoietic stem cells (HSC) is an act of altruism, and may be to a recipient in a different country, with quite different moral, cultural and religious values.

Whilst it is recognised that the process of donation carries a small but unavoidable risk of harm to the donor, it is both the moral and legal responsibility of donor registries and donor centres to minimise any avoidable risk. This includes medical conditions that may increase the risk of harm to the donor before, during, and after the collection of HSC.

For this reason, medical criteria governing conditions that may increase donor risk are necessarily stringent, and certainly more so than would be the case if the individual were undergoing a procedure for therapeutic benefit.

In many cases it is difficult to establish a rigorous evidence base as justification for the criteria. In such cases, expert opinion of the underlying physiology of disease will be sought, and combined with knowledge of the known physiological changes associated with donation, as well as experience gained through several decades of HSC donor follow-up and adverse event reporting.

In general, if there is any doubt about the safety of the donor in the presence of a particular medical condition, it will be recommended that any donor with that condition be prevented from donating.

Recipient risk

By contrast, our recommendations regarding conditions that may put the recipient at risk are more lenient.

For many patients, an unrelated donor HSC transplant represents the only possibility of disease cure or long-term remission. Because of the diverse nature of HLA tissue-types, many patients will have a limited number of potentially matched donors. In such cases, donor medical conditions that may present a risk to the recipient alone should be reported to the transplant centre, who are best placed to make an informed risk-benefit judgement on whether to proceed with that particular donor.

There are obvious exceptions to this, however, in particular the carriage of transmissible agents which may have more deleterious effects in the recipient. These include infectious agents such as HIV, viral hepatitis and HTLV, prion-related diseases such as Creutzfeld-Jakob Disease, and carriage of auto-reactive lymphocytes causing multi-system or severe single-organ autoimmune diseases, such as systemic lupus erythematosus, multiple sclerosis or inflammatory bowel disease.

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Procedure for creating and reviewing the donor medical suitability guidelines

To create and support this resource, the WMDA has established the donor medical suitability committee. Members of the committee represent all major regions in the world, and are themselves overseen by numerous competent authorities within their country of practice. Committee members are actively involved in donor centre and/or registry operations with experience in matters concerning unrelated donor medical suitability. You can find the members here: https://share.wmda.info/x/So1JAQ.

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Submitting a request for review

WMDA welcomes requests for review of individual medical conditions from all those with responsibility for HSC donors, related or unrelated. This may be a medical condition not covered by the current guidance, or a request for clarification or review of current guidance. Requests for new guidance, and feedback on existing guidance, are submitted to the donor medical suitability committee. Comments and justifications for the committee decision are documented, including justification for the decision. Regardless of the outcome, a formal response to the query is provided to the author of each submission in order to inform the registry/donor centre of the outcome of the discussion. Recommendations that are approved are posted to this website. Any controversies pertaining to the recommendations are added to the discussion section on the relevant page. You can click on the button on the right top corner of the page.

Table 5 - Recommended schedule of repeating donor assessments in the event of a delay to collection

Schedule for repeating donor assessments in the event of a delay to collection and in case of subsequent donation

Time from work-up medical assessment to collection

Repeat assessments required

<=30 days

None

>30 days, <90 days

Required:

Infectious disease markers

Risk assessment1 for transmittable disease

Full donor history if subsequent donation

Optional2:

Full donor history if first donation

Physical examination

All laboratory testing excluding hemoglobinopathy screening

Additional testing

>=90 days, <6months

Required:

Infectious disease markers

Risk assessment for transmittable disease

Full donor history if subsequent donation

All laboratory testing excluding hemoglobinopathy screening

Optional:

Full donor history if first donation

Physical examination

Additional testing

>=6 months

Required:

Infectious disease markers

Full donor history including risk assessment for transmittable disease

Physical examination

All laboratory testing excluding hemoglobinopathy screening

Recommended

ECG

Optional (per discretion of physician in charge):

Additional testing such as Chest X-ray or abdominal ultrasound.

1Risk assessment does not necessary mean a full risk questionnaire, but means a risk assessment based on local policies, endemic risks and previous individual risk assessments and/or Infectious disease marker results. Especially in young donors a travel history seems appropriate.

2Optional: per discretion of the donor physician in charge or as required by standards or (national) legislation.